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Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

Primary Purpose

Cigarette Smoking, Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
varenicline
placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cigarette Smoking

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-64
  • Regular ten cigarette per day smoker for one year
  • Nicotine Dependency Score greater than or equal to four
  • DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
  • Psychiatric medication regimen unchanged for at least 90 days
  • Psychiatric medication dosage unchanged for at least 30 days

Exclusion Criteria:

  • Psychiatric hospitalization in last 6 months
  • Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
  • Suicide or homicide ideation with a plan in the last six months
  • Life time history of suicide attempt
  • Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
  • Current treatment with Bupropion SR
  • DSM-IV diagnosis of alcohol or substance dependence within last 6 months*
  • DSM-IV diagnosis of alcohol or substance abuse within three months *
  • Pregnancy or lactation in females (+HCG)
  • Use of tobacco product other than cigarettes
  • Use of nicotine replacements
  • Unstable or serious medical condition in last 6 months
  • Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    varenicline

    placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change of ExpiredCO Level From Baseline
    End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
    Level of Nicotine Dependence by Treatment Assignment
    Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.

    Secondary Outcome Measures

    Brief Psychiatric Rating Scale (BPRS) - Total Score
    The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
    Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
    The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
    Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
    The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating.
    Side Effects
    Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.

    Full Information

    First Posted
    November 6, 2007
    Last Updated
    March 16, 2022
    Sponsor
    University of Maryland, Baltimore
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00554840
    Brief Title
    Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
    Official Title
    Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.
    Detailed Description
    The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of < 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cigarette Smoking, Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    varenicline
    Arm Type
    Active Comparator
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    varenicline
    Other Intervention Name(s)
    chantix, study drug
    Intervention Description
    Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    sugar pill
    Intervention Description
    At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
    Primary Outcome Measure Information:
    Title
    Change of ExpiredCO Level From Baseline
    Description
    End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
    Time Frame
    Weekly for 12 weeks
    Title
    Level of Nicotine Dependence by Treatment Assignment
    Description
    Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
    Time Frame
    Weekly for 12 weeks
    Secondary Outcome Measure Information:
    Title
    Brief Psychiatric Rating Scale (BPRS) - Total Score
    Description
    The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
    Time Frame
    Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
    Title
    Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
    Description
    The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
    Time Frame
    Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
    Title
    Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
    Description
    The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating.
    Time Frame
    Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
    Title
    Side Effects
    Description
    Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.
    Time Frame
    Weekly for 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-64 Regular ten cigarette per day smoker for one year Nicotine Dependency Score greater than or equal to four DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder Psychiatric medication regimen unchanged for at least 90 days Psychiatric medication dosage unchanged for at least 30 days Exclusion Criteria: Psychiatric hospitalization in last 6 months Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria) Suicide or homicide ideation with a plan in the last six months Life time history of suicide attempt Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years Current treatment with Bupropion SR DSM-IV diagnosis of alcohol or substance dependence within last 6 months* DSM-IV diagnosis of alcohol or substance abuse within three months * Pregnancy or lactation in females (+HCG) Use of tobacco product other than cigarettes Use of nicotine replacements Unstable or serious medical condition in last 6 months Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elaine Weiner, M.D.
    Organizational Affiliation
    Maryland Psychiatric Research Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

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